Requirements for Informed Consent

7/27/2019 Requirements for Informed Consent

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ByAdemola J. Ajuwon, MPH, PhD

Department of Health Promotion and Education,College of Medicine,University of Ibadan

Email: [email protected]


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Informed consent is a decision to participate in research, taken by acompetent individual who has received the necessary information; who has adequately understood the information; and who after considering the information has arrived at a decision(voluntarily) without been subjected to coercion, undue influence or

intimidation (CIOMS, 2002)

Understanding and voluntary decision are essential componentsof the informed consent process Understood Consent and Informed Dissent are two sides a coin


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A type of contract between an investigatorand a study participant

The contract is sealed by the signing of theInformed Consent Form by the participant

The form spells out the responsibilities of

investigators and the rights of studyparticipants


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Is an ongoing process and more than mereritual of signing a paper

Adequate time and resources must be set

aside for the process to be meaningful

Investigators and those involved in takingconsent must be available to answer

questions before and every time during theresearch (CIOMS, 2002)


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Informed consent is a sine qua nonfor ethicalconduct of research (page 37)


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Adequate information must be provided in a language thatthe participant understands

(the language must not be higher than that of individuals withat most 9 years of education in Nigeria page 37)

Consent forms must not be longer than 8 pages in order toensure comprehensibility and enhance recall of pertinentinformation

Unnecessary jargons and technical and legalistic terms mustbe avoided


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Paper size A4

Font Times New Roman or similar

Font Size 12

Spacing 1.5

Margins 2.5 cm, no gutter


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1. Title of the research

2. Name (s) and affiliation (s) of the researcher (s)

3. Sponsor (s) of research

4. Purpose (s) of research

5. Procedure of the research, what shall be required of each participant andapproximate total number of participants that would be involved in the research.

6. Expected duration of research and of participant (s) involvement.

7. Risk (s)

8. Costs to the participants, if any, of joining the research

9. Benefit (s)

10. Confidentiality

11. Voluntariness


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12. Alternatives to participation13. Incentive (inducement) to participants14. Consequences of participants decision to withdraw from research andprocedure for orderly termination of participation.15. Modality of providing treatments and action(s) to be taken in case of injuryor adverse event(s).16. What happens to research participants and communities when the researchis over?17. Statement about sharing of benefits among researchers and whether thisincludes or exclude research participants.18. Any apparent or potential conflict of interest.19. Detailed contact information including contact address, telephone, fax, e-mailand any other contact information of researcher (s), institutional HREC and headof the institution.


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1. Research participants are entitled to retain a copy of theconsent form.

2. Where appropriate, researcher (s) may be required toundertake a re-consenting process during the course ofresearch as determined by the HREC.

3. In situations where participant (s) are unable to providewritten consent, researcher (s) must propose a process ofconsent that adequately records participants informeddecision such as witnessed thumb-printing or witnessedaudio recording.

4. HREC may require that all or some types of consent processbe witnessed.


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5. Researcher(s) must keep all copies of consent form and make

them available for examination by participant(s), sponsor(s),institution(s), HREC and NHREC.

6. Where appropriate, HREC may require researchers to provide

translations of consent processes appropriate to the socio-cultural characteristics of the population to be studied.

7. All consent activities must be documented.


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A perception that spending sufficient time forconsent is a waste of time because

a) Researchers or their Assistants are under pressureto recruit as many study participants are possiblein a short time

b) Study population do not know their rights anywayso why worry?

c) Perception that researcher is doing studyparticipants a favour; this may apply if health careis a component of study


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Culture of not challenging medical authority (the distinction betweencare and research may not very clear when the physician is alsoresearcher)

Physicians have credibility and great influence over patients becauseof belief that a doctor will always do good for his/her patient

Patients who are potential participants may be under subtle pressureto enroll in research because of concerns that quality of care may beadversely affected if the give refuse to participate

Researchers working in teaching hospitals may perceive thatinformed consent is not necessary since patients who come to such

hospitals have given assumed consent


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Gender issues In many traditional settings in Nigeria, access to women during community-

based research requires permission of husbands

In many areas Nigerian women require the permission of husbands beforeenrolling in studies

Will women who are interested in participating in a research give consent iftheir husbands disapprove that they enroll?

If receiving informed consent from women is evidence of respect for theirdignity and autonomy why is permission of husbands required before womencan give consent to participate research? Many Nigerian women are poor and have been socially conditioned to submitto authority figures including husbands, to ask no questions, and to endurepain and suffering encountered in marriage (CIOMS, 2003)


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One of the essential requirements of informedconsent is full disclosure of the purpose ofresearch to enable potential research participantsmake informed decision

However, full disclosure is often tricky in sensitivereproductive health research such as gender-basedviolence because if a perpetrator knows that thefocus of the research is violence it may triggermore violence

Yet, women need to be fully informed about thenature of and procedures involved in a researchbefore they decide to participate in the research


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Tension between community assent and individualconsent

Is obtaining permission from a community leader,chief or another designated authority in a

community sufficient to serve as individualconsent?

What happens when a gate-keeper do not giveapproval for a research that will potentially be of

benefit to some members of the community?

Possible reasons: corruption, previous badexperience, lack of trust of investigators


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Nigerians are skeptical about all forms ofdocumentation:

Fear that information may be used for non-beneficial purposes

Many are low literate or non-literate

Previous bad experiences during colonial period

Some prefer verbal consent to written consentbecause of belief that the former is less committal


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Continuing education of the importance of consentfor the public, researchers, members of ERC, andsponsors of research

Strengthening of the capacity of ERC to enable

them monitor consent process of approvedresearch

ERC need to set minimum standards fordevelopment of consent forms and how to apply

them in the field

Promotion gender equality


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Council for international organizations ofMedical Sciences. International ethicalGuidelines for biomedical research involvinghuman subjects. Geneva, 2002

Getz K and Borfitz D. Informed Consent: Aguide to risks and benefits of vounteering for

clinical trials. Thomson/CenterWatch, 2003

National Health Research Ethics Code, 2007

Requirements for Informed Consent

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